{"id":"dexbrompheniramine","rwe":[{"pmid":"30000837","year":"2006","title":"Dexbrompheniramine.","finding":"","journal":"","studyType":"Clinical Study"},{"pmid":"40823550","year":"2025","title":"Genetic insights into alcohol-associated liver disease: integrative transcriptome-wide analysis identifies novel susceptibility genes.","finding":"","journal":"Frontiers in medicine","studyType":"Clinical Study"},{"pmid":"40287959","year":"2025","title":"Designing highly efficient heterocyclic inhibitors for SARS-CoV-2 3C-like proteinase: a comprehensive in silico study.","finding":"","journal":"Journal of biomolecular structure & dynamics","studyType":"Clinical Study"},{"pmid":"19085565","year":"2008","title":"Transient receptor potential vanilloid-1-mediated calcium responses are inhibited by the alkylamine antihistamines dexbrompheniramine and chlorpheniramine.","finding":"","journal":"Experimental lung research","studyType":"Clinical Study"},{"pmid":"18967858","year":"2000","title":"Simultaneous determination of pseudoephedrine sulfate, dexbrompheniramine maleate and loratadine in pharmaceutical preparations using derivative spectrophotometry and ratio spectra derivative spectrophotometry.","finding":"","journal":"Talanta","studyType":"Clinical Study"}],"_fda":{"id":"4513db4f-e8f2-ecc6-e063-6294a90a1b17","set_id":"0d203b5c-8b10-428b-8703-17be6b4ce6eb","openfda":{"upc":["0350991783605"],"unii":["BPA9UT29BS"],"route":["ORAL"],"rxcui":["2262293","2262295"],"spl_id":["4513db4f-e8f2-ecc6-e063-6294a90a1b17"],"brand_name":["ALA-HIST IR"],"spl_set_id":["0d203b5c-8b10-428b-8703-17be6b4ce6eb"],"package_ndc":["50991-783-02","50991-783-60"],"product_ndc":["50991-783"],"generic_name":["DEXBROMPHENIRAMINE MALEATE"],"product_type":["HUMAN OTC DRUG"],"substance_name":["DEXBROMPHENIRAMINE MALEATE"],"manufacturer_name":["Poly Pharmaceuticals, Inc."],"application_number":["M012"],"is_original_packager":[true]},"purpose":["Purpose Antihistamine"],"version":"11","warnings":["Warnings Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product excitability may occur, especially in children may cause drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase the drowsiness effect use caution when driving a motor vehicle or operating machinery If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"questions":["Questions? Call 1-800-882-1041 Manufactured for: Poly Pharmaceuticals Quitman, MS 39355 Rev. 02/12"],"when_using":["When using this product excitability may occur, especially in children may cause drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase the drowsiness effect use caution when driving a motor vehicle or operating machinery If pregnant or breast-feeding, ask a health professional before use."],"effective_time":"20251203","active_ingredient":["Drug Facts Active ingredients (in each tablet) Dexbrompheniramine Maleate 2 mg Purpose Antihistamine"],"inactive_ingredient":["Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C Blue #1 aluminum lake, FD&C Yellow #5 aluminum lake, magnesium stearate, and silicified microcrystalline cellulose."],"storage_and_handling":["Other information Store at 15° - 30°C (59° - 86°F). Supplied in a tight, light-resistant container with a child-resistant cap. Contains color additives including FD&C Yellow No. 5 (tartrazine). Ala-Hist IR Tablets are dark green caplet shaped, scored tablets, debossed \"Poly\" bisect \"783\" on one side and plain on the other."],"indications_and_usage":["Uses Temporarily relieves these symptoms due to hay fever (allergic rhinitis) or upper respiratory allergies: runny nose sneezing itching of the nose or throat itchy, watery eyes"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product excitability may occur, especially in children may cause drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase the drowsiness effect use caution when driving a motor vehicle or operating machinery If pregnant or breast-feeding, ask a health professional before use."],"dosage_and_administration":["Directions Adults and children 12 years of age and over: 1 tablet every 4 to 6 hours, not to exceed 6 tablets in 24 hours. Children 6 to under 12 years of age: 1/2 tablet every 4 to 6 hours, not to exceed 3 tablets in 24 hours. Children under 6 years of age: Consult a doctor."],"spl_product_data_elements":["ALA-HIST IR Dexbrompheniramine Maleate CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE SILICON DIOXIDE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE DEXBROMPHENIRAMINE MALEATE DEXBROMPHENIRAMINE dark green Poly;783"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"dosage_and_administration_table":["<table width=\"500px\"><col/><col/><tbody><tr><td valign=\"top\">Adults and children  12 years of age and  over: </td><td valign=\"top\">1 tablet every 4 to 6  hours, not to exceed  6 tablets in 24 hours. </td></tr><tr><td valign=\"top\">Children 6 to under  12 years of age: </td><td valign=\"top\">1/2 tablet every 4 to 6  hours, not to exceed  3 tablets in 24 hours. </td></tr><tr><td valign=\"top\">Children under 6  years of age: </td><td valign=\"top\">Consult a doctor. </td></tr></tbody></table>"],"package_label_principal_display_panel":["Product Packaging The packaging below represents the labeling currently used. Principal display panel and side panel for 60 tablets label: NDC 50991-783-60 ALA-HIST IR 2 mg Tablets Antihistamine Each tablet contains: Dexbrompheniramine Maleate.........2 mg 60 Tablets Usual Dosage: See product foldout for full prescribing information Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing. KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN. Store at controlled room temperature 15°-30°C (59°-86°F). Manufactured for: Poly Pharmaceuticals Rev. 02/12 label insert"]},"tags":[{"label":"dexbrompheniramine","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Histamine H1 receptor","category":"target"},{"label":"HRH1","category":"gene"},{"label":"R06AB06","category":"atc"},{"label":"Oral","category":"route"},{"label":"Liquid","category":"form"},{"label":"Solution","category":"form"},{"label":"Syrup","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Active","category":"status"},{"label":"Allergic conjunctivitis","category":"indication"},{"label":"Allergic rhinitis","category":"indication"},{"label":"Dermatographic urticaria","category":"indication"},{"label":"Influenza-like symptoms","category":"indication"},{"label":"Itching of skin","category":"indication"},{"label":"Seasonal allergic rhinitis","category":"indication"},{"label":"Schering Plough","category":"company"},{"label":"Approved 1960s","category":"decade"},{"label":"Histamine Agents","category":"pharmacology"},{"label":"Histamine Antagonists","category":"pharmacology"},{"label":"Histamine H1 Antagonists","category":"pharmacology"},{"label":"Neurotransmitter Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"34 reports"},{"date":"","signal":"ANXIETY","source":"FDA FAERS","actionTaken":"29 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"23 reports"},{"date":"","signal":"ARTHRALGIA","source":"FDA FAERS","actionTaken":"16 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"16 reports"},{"date":"","signal":"DEPRESSION","source":"FDA FAERS","actionTaken":"15 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"15 reports"},{"date":"","signal":"PAIN IN EXTREMITY","source":"FDA FAERS","actionTaken":"15 reports"},{"date":"","signal":"BRONCHITIS","source":"FDA FAERS","actionTaken":"14 reports"},{"date":"","signal":"COUGH","source":"FDA FAERS","actionTaken":"14 reports"}],"contraindications":["Acidosis","Acute abdominal pain","Acute hepatitis","Acute pancreatitis","Alcohol intoxication","Alcohol withdrawal delirium","Alcoholism","Angle-closure glaucoma","Arterial thrombosis","Arteriosclerotic vascular disease","Asthenia","Benign intracranial hypertension","Benign prostatic hyperplasia","Bladder outflow obstruction","Bradycardia","Central nervous system depression","Chronic heart failure","Chronic idiopathic constipation","Coma","Conduction disorder of the heart","Constipation","Cor pulmonale","Coronary arteriosclerosis","Decreased respiratory function","Dehydration"]},"trials":[],"aliases":[],"company":"Merck & Co.","patents":[],"pricing":[],"_fixedAt":"2026-03-30T15:52:45.766043","_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=DEXBROMPHENIRAMINE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:11:56.808701+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:12:04.802705+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=DEXBROMPHENIRAMINE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:12:05.574268+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:11:54.571038+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:11:54.571080+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T00:12:07.232780+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1201287/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:12:06.205489+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"M012","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:11:54.571087+00:00"}},"allNames":"drixoral","offLabel":[],"synonyms":["dexbrompheniramine","d-Brompheniramine","(+)-Brompheniramine","dexbrompheniramine maleate"],"timeline":[{"date":"1963-10-18","type":"positive","source":"DrugCentral","milestone":"FDA approval (Schering Plough)"}],"approvals":[{"date":"1963-10-18","orphan":false,"company":"SCHERING PLOUGH","regulator":"FDA"}],"brandName":"Drixoral","ecosystem":[{"indication":"Allergic conjunctivitis","otherDrugs":[{"name":"acrivastine","slug":"acrivastine","company":"Auxilium Pharms Inc"},{"name":"alcaftadine","slug":"alcaftadine","company":"Allergan"},{"name":"alimemazine","slug":"alimemazine","company":"Allergan Herbert"},{"name":"antazoline","slug":"antazoline","company":"Novartis"}],"globalPrevalence":null},{"indication":"Allergic rhinitis","otherDrugs":[{"name":"acrivastine","slug":"acrivastine","company":"Auxilium Pharms Inc"},{"name":"alimemazine","slug":"alimemazine","company":"Allergan Herbert"},{"name":"antazoline","slug":"antazoline","company":"Novartis"},{"name":"astemizole","slug":"astemizole","company":""}],"globalPrevalence":null},{"indication":"Dermatographic urticaria","otherDrugs":[{"name":"alimemazine","slug":"alimemazine","company":"Allergan Herbert"},{"name":"antazoline","slug":"antazoline","company":"Novartis"},{"name":"azatadine","slug":"azatadine","company":""},{"name":"brompheniramine","slug":"brompheniramine","company":""}],"globalPrevalence":68000000},{"indication":"Influenza-like symptoms","otherDrugs":[{"name":"acetylsalicylic acid","slug":"acetylsalicylic-acid","company":"Endo Pharms"},{"name":"brompheniramine","slug":"brompheniramine","company":""},{"name":"caffeine","slug":"caffeine","company":"Novartis"},{"name":"chlorphenamine","slug":"chlorphenamine","company":"Bayer Healthcare Llc"}],"globalPrevalence":null},{"indication":"Itching of skin","otherDrugs":[{"name":"alimemazine","slug":"alimemazine","company":"Allergan Herbert"},{"name":"allantoin","slug":"allantoin","company":""},{"name":"ammonium lactate","slug":"ammonium-lactate","company":"Ranbaxy"},{"name":"antazoline","slug":"antazoline","company":"Novartis"}],"globalPrevalence":null},{"indication":"Seasonal allergic rhinitis","otherDrugs":[{"name":"acrivastine","slug":"acrivastine","company":"Auxilium Pharms Inc"},{"name":"azatadine","slug":"azatadine","company":""},{"name":"azelastine","slug":"azelastine","company":"Meda Pharms"},{"name":"brompheniramine","slug":"brompheniramine","company":""}],"globalPrevalence":null},{"indication":"Urticaria","otherDrugs":[{"name":"alimemazine","slug":"alimemazine","company":"Allergan Herbert"},{"name":"antazoline","slug":"antazoline","company":"Novartis"},{"name":"azatadine","slug":"azatadine","company":""},{"name":"brompheniramine","slug":"brompheniramine","company":""}],"globalPrevalence":68000000},{"indication":"Vasomotor rhinitis","otherDrugs":[{"name":"acrivastine","slug":"acrivastine","company":"Auxilium Pharms Inc"},{"name":"antazoline","slug":"antazoline","company":"Novartis"},{"name":"azatadine","slug":"azatadine","company":""},{"name":"azelastine","slug":"azelastine","company":"Meda Pharms"}],"globalPrevalence":null}],"mechanism":{"target":"Histamine H1 receptor","novelty":"Follow-on","targets":[{"gene":"HRH1","source":"DrugCentral","target":"Histamine H1 receptor","protein":"Histamine H1 receptor","isPrimary":true,"activityType":"","activityValue":null}],"modality":"Small Molecule","drugClass":"dexbrompheniramine","explanation":"","oneSentence":"","technicalDetail":"Dexbrompheniramine is a selective H1 receptor antagonist that competes with histamine for binding sites on the receptor, thereby inhibiting the histamine-mediated response and alleviating symptoms of allergic conditions."},"commercial":{"launchDate":"1963","_launchSource":"DrugCentral (FDA 1963-10-18, SCHERING PLOUGH)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/830","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=DEXBROMPHENIRAMINE","fields":["publications"],"source":"PubMed/NCBI"},{"id":3,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T10:36:41.440507","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:12:09.016471+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"brompheniramine","drugSlug":"brompheniramine","fdaApproval":"1957-08-23","genericCount":13,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"dexchlorpheniramine","drugSlug":"dexchlorpheniramine","fdaApproval":"1981-07-14","genericCount":4,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"chlorphenamine","drugSlug":"chlorphenamine","fdaApproval":"1950-08-15","relationship":"same-class"},{"drugName":"pheniramine","drugSlug":"pheniramine","fdaApproval":"1994-06-08","relationship":"same-class"}],"genericName":"dexbrompheniramine","indications":{"approved":[{"name":"Allergic conjunctivitis","source":"DrugCentral","snomedId":473460002,"regulator":"FDA"},{"name":"Allergic rhinitis","source":"DrugCentral","snomedId":61582004,"regulator":"FDA"},{"name":"Dermatographic urticaria","source":"DrugCentral","snomedId":7632005,"regulator":"FDA","usPrevalence":null,"globalPrevalence":68000000,"prevalenceMethod":"curated","prevalenceSource":"Allergy, 2020 (PMID:31494963)"},{"name":"Influenza-like symptoms","source":"DrugCentral","snomedId":315642008,"regulator":"FDA"},{"name":"Itching of skin","source":"DrugCentral","snomedId":418363000,"regulator":"FDA"},{"name":"Seasonal allergic rhinitis","source":"DrugCentral","snomedId":367498001,"regulator":"FDA"},{"name":"Urticaria","source":"DrugCentral","snomedId":126485001,"regulator":"FDA","eligibility":null,"usPrevalence":null,"globalPrevalence":68000000,"prevalenceMethod":"curated","prevalenceSource":"Allergy, 2020 (PMID:31494963)"},{"name":"Vasomotor rhinitis","source":"DrugCentral","snomedId":8229003,"regulator":"FDA"}],"offLabel":[],"pipeline":[]},"_fixedFields":["primaryTarget"],"drugCategory":"active","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"brompheniramine","brandName":"brompheniramine","genericName":"brompheniramine","approvalYear":"1957","relationship":"same-class"},{"drugId":"dexchlorpheniramine","brandName":"dexchlorpheniramine","genericName":"dexchlorpheniramine","approvalYear":"1981","relationship":"same-class"},{"drugId":"chlorphenamine","brandName":"chlorphenamine","genericName":"chlorphenamine","approvalYear":"1950","relationship":"same-class"},{"drugId":"pheniramine","brandName":"pheniramine","genericName":"pheniramine","approvalYear":"1994","relationship":"same-class"}],"trialDetails":[],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Oral","formulation":"Liquid, Solution, Syrup","formulations":[{"form":"LIQUID","route":"ORAL","productName":"G-Con-X"},{"form":"LIQUID","route":"ORAL","productName":"WesTussin DM NF"},{"form":"LIQUID","route":"ORAL","productName":"ACTICON"},{"form":"LIQUID","route":"ORAL","productName":"ALAHISTDM"},{"form":"LIQUID","route":"ORAL","productName":"BIO-CNEX"},{"form":"LIQUID","route":"ORAL","productName":"BionatussDXP"},{"form":"LIQUID","route":"ORAL","productName":"BranTussin DM"},{"form":"LIQUID","route":"ORAL","productName":"Chlo Hist"},{"form":"LIQUID","route":"ORAL","productName":"Chlo Tuss"},{"form":"LIQUID","route":"ORAL","productName":"Conex"},{"form":"LIQUID","route":"ORAL","productName":"Dexbrompheniramine-DM-Phenylephrine 2-15-7.5"},{"form":"LIQUID","route":"ORAL","productName":"M-ENDDMX"},{"form":"LIQUID","route":"ORAL","productName":"Polytussin DM"},{"form":"SOLUTION","route":"ORAL","productName":"ACTICON"},{"form":"SYRUP","route":"ORAL","productName":"PediaVent"}]},"_patentsChecked":true,"crossReferences":{"NUI":"N0000147803","MMSL":"4555","NDDF":"003411","UNII":"75T64B71RP","VUID":"4019711","CHEBI":"CHEBI:59269","VANDF":"4018841","INN_ID":"907","RXNORM":"22696","UMLSCUI":"C0057605","chemblId":"CHEMBL1201287","ChEMBL_ID":"CHEMBL1201287","KEGG_DRUG":"D03704","DRUGBANK_ID":"DB00405","PUBCHEM_CID":"16960","SNOMEDCT_US":"387090008","IUPHAR_LIGAND_ID":"7588","SECONDARY_CAS_RN":"2391-03-9","MESH_SUPPLEMENTAL_RECORD_UI":"C015121"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"1963-","companyName":"Schering Plough","relationship":"Original Developer"}],"publicationCount":44,"therapeuticAreas":["Infectious Disease"],"atcClassification":{"source":"DrugCentral","atcCode":"R06AB06","allCodes":["R06AB06","R06AB56"]},"biosimilarFilings":[],"originalDeveloper":"Schering Plough","recentPublications":[{"date":"2006","pmid":"30000837","title":"Dexbrompheniramine.","journal":""},{"date":"2025","pmid":"40823550","title":"Genetic insights into alcohol-associated liver disease: integrative transcriptome-wide analysis identifies novel susceptibility genes.","journal":"Frontiers in medicine"},{"date":"2025 Nov","pmid":"40287959","title":"Designing highly efficient heterocyclic inhibitors for SARS-CoV-2 3C-like proteinase: a comprehensive in silico study.","journal":"Journal of biomolecular structure & dynamics"},{"date":"2008 Dec","pmid":"19085565","title":"Transient receptor potential vanilloid-1-mediated calcium responses are inhibited by the alkylamine antihistamines dexbrompheniramine and chlorpheniramine.","journal":"Experimental lung research"},{"date":"2000 Feb 7","pmid":"18967858","title":"Simultaneous determination of pseudoephedrine sulfate, dexbrompheniramine maleate and loratadine in pharmaceutical preparations using derivative spectrophotometry and ratio spectra derivative spectrophotometry.","journal":"Talanta"}],"companionDiagnostics":[],"genericManufacturers":0,"_genericFilersChecked":true,"genericManufacturerList":[],"status":"approved","companyName":"Merck & Co.","companyId":"merck","modality":"Small molecule","firstApprovalDate":"1963","aiSummary":"","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":"1963-10-18T00:00:00.000Z","mah":"SCHERING PLOUGH","brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":"1963-10-18T00:00:00.000Z","mah":"SCHERING PLOUGH","brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":"1963-10-18T00:00:00.000Z","mah":"SCHERING PLOUGH","brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":"1963-10-18T00:00:00.000Z","mah":"SCHERING PLOUGH","brand_name_local":null,"application_number":null},{"country_code":"SA","regulator":"SFDA","status":"likely_approved","approval_date":"1963-10-18T00:00:00.000Z","mah":"SCHERING PLOUGH","brand_name_local":null,"application_number":null},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1963-10-18T00:00:00.000Z","mah":"SCHERING PLOUGH","brand_name_local":null,"application_number":""},{"country_code":"IN","regulator":"CDSCO","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TH","regulator":"FDA-TH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"MY","regulator":"NPRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"PH","regulator":"FDA-PH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"CO","regulator":"INVIMA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"ZA","regulator":"SAHPRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TW","regulator":"TFDA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"HK","regulator":"DH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"BR","regulator":"ANVISA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"MX","regulator":"COFEPRIS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AR","regulator":"ANMAT","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TR","regulator":"TITCK","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:12:09.016471+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"enriching","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":false,"score":1}}